Group-Sequential Clinical Trials with Multiple Co-Objectives

• Main Authors: Hamasaki, Toshimitsu (Author), Asakura, Koko (Author), Evans, Scott R. (Author), Ochiai, Toshimitsu (Author)
• Corporate Author: SpringerLink (Online service)
• Format: Electronic eBook
• Language: English
• Published: Tokyo : Springer Japan : Imprint: Springer, 2016.
• Series: SpringerBriefs in Statistics,
• Subjects: Statistics.; Statistical Theory and Methods.; Statistics for Life Sciences, Medicine, Health Sciences.; Statistics for Social Science, Behavorial Science, Education, Public Policy, and Law.

This book focuses on group sequential methods for clinical trials with co-primary endpoints based on the decision-making frameworks for: (1) rejecting the null hypothesis (stopping for efficacy), (2) rejecting the alternative hypothesis (stopping for futility), and (3) rejecting the null or alternat...

Table of Contents:

• 1. Introduction
• 2. Early Stopping for Efficacy in Clinical Trials with multiple co-primary endpoints
• 3. Sample size recalculation based on observed effects at interim
• 4. Early stopping for futility in Clinical Trials with multiple co-primary endpoints
• 5. Early stopping for futility or Efficacy in Clinical Trials with multiple co-primary endpoints
• 6. Clinical Trials with multiple primary endpoints
• 7. Group-sequential designs for three-arm noninferiority clinical trials
• 8. Further development: topics not covered in this book.